BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2677120 · Received July 27, 2012

    Report

    Report Number
    1119421-2012-00953
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 29, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE CARTRIDGE BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY FAX AND MAIL ON 07/02/2012. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/02/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO WAS RECEIVED FROM THE TECH WHO REPORTED THE OUTCOME OF THE EVENT FOR THE PT IS UNKNOWN. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS PERFORMED. THE LENS IS IN THE BAG WITHOUT CAPSULE OPACITY. IN THE SURGEON'S OPINION, IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 11077655

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other DUOVISC:| MONARCH HANDPIECE II:| MONARCH CARTRIDGE B: